Status:
COMPLETED
Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Shire
Conditions:
Hyperphosphatemia
Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients with end-stage renal disease (ESRD) commonly develop hyperphosphatemia due to the loss of excretory function of the kidney. This in turn may lead to the development of secondary hyperparathyr...
Detailed Description
Study subjects Men and women at least 18 years of age, receiving HD for at least 3 months, with serum P concentrations 45.5 mg/dL at the end of the washout period, and on a stable dose of P binder and...
Eligibility Criteria
Inclusion
- Male or female 18 years of age or older
- Have been on hemodialysis for at least 3 months
- Women of child-bearing potential (premenopausal and not surgically sterilized) who have a negative serum pregnancy test
- On a stable dose of phosphate binder for at least 1 month prior to the study
- On a stable dose of active vitamin D (if previously prescribed) for at least 1 month prior to the study
- Serum phosphorus concentrations \> 5.5 mg/dL (1.78 mmol/L) at the end of the washout period
Exclusion
- Did not previously respond to phosphate binder therapy
- Known non-compliance with oral medications
- Severe hyperparathyroidism defined as intact-PTH (i-PTH) \> 500 pg/ml
- Taking any calcium-, magnesium- or aluminum-containing antacids
- Use of an investigational agent within 30 days of study entry
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00660530
Start Date
January 1 2008
End Date
November 1 2009
Last Update
November 3 2020
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612